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The Pharmacovigilance System in Europe – Chinese

$99.00

In response to the global need for training in pharmacovigilance and the regulation changes in Europe, Meditrial has developed a series of e-learning courses covering different aspects of the science of medicines safety.

Meditrial’s e-learning courses take a micro-learning approach, with short, concise lessons connected to clear learning objectives. Most courses are taught in English, with subtitles in English. Courses are also available in other languages such as German, Italian and Chinese. Upon completing a course, you will take a final test to receive a digital certificate that can be printed.

The broad collection of self-paced e-learning courses is suitable to health professionals with an interest in pharmacovigilance. Courses are made available free of charge to those working at pharmacovigilance centres or in the public sector (hospitals, pharmacies, academia etc.). For those working at for-profit organisations or companies (pharmaceutical companies, contract research organisations etc.), the courses will be made available for a fee. Please visit our e-learning platform to enrol and learn more about the course content.

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Description

Why take this course

In this course you will learn about Pharmacovigilance or drug safety during the conduct of a clinical trial and the post-marketing experience of a drug.

What I will learn

We will cover an overview of the world of pharmacovigilance, and we will focus on the main activities to be carried out in this area, as well as examine the purpose of pharmacovigilance in clinical research to determine whether the benefits outweigh the risks; with the ultimate aim of ensuring the safest use of a drug and to comply with the legal requirements on pharmacovigilance.

Skills I will gain

  • Analyze why Pharmacovigilance is necessary to clinical research
  • Review what is necessary for safe data management through out clinical trials of drugs
  • Cover correct reporting and management procedures
  • Examine proper PSUR elaboration and submission

 

Course Topics

In this course we will see an overview of the world of pharmacovigilance, and we will focus on the main activities to be carried out in this area with the ultimate aim of ensuring the safest use of a drug and to comply with the legal requirements on pharmacovigilance.

  • PHARMACOVIGILANCE IN EUROPE – OVERVIEW (00:05:30)

The aim of the course is to illustrate the main safety activities to be implemented while conducting a clinical study.

  • SAFETY MONITORING AND REPORTING FOR CLINICAL TRIALS IN EUROPE (00:10:26)

 

  • Final Quiz – Pharmacovigilance Pre and Post Market Experience
  • Course evaluation survey
  • Certification

Additional information

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